Kub Technologies, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Kub Technologies, Inc.” (first 2007, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 148 days. Since 2017 the median was 154 days, against 53 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 141 |
| 2015 | 1 | 47 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 176 |
| 2020 | 1 | 80 |
| 2021 | 3 | 154 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kub Technologies, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 53 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWP | Cabinet, X-Ray System | 6 | 6 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Review panels
- Radiology (10)
Most recent Kub Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | MWP | 2021-09-20 | 174 |
| K210957 | Kubec Xpert 80 Radiography System | MWP | 2021-08-31 | 154 |
| K210956 | Kubtec Mozart (XPERT42) | MWP | 2021-08-31 | 154 |
| K200756 | Kubtec Mozart Supra | MWP | 2020-06-12 | 80 |
| K183624 | Kubtec Mozart (Xpert42) | MWP | 2019-06-20 | 176 |
| K151221 | Kubtec DIGIVIEW 395 | MQB | 2015-06-23 | 47 |
| K141539 | KUBTEC X250 | IZL | 2014-10-29 | 141 |
| K103348 | DIGIVIEW 250 | MQB | 2011-10-20 | 339 |
| K083510 | KUBTEC XPERT 20 | KPR | 2009-01-08 | 43 |
| K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | MWP | 2007-06-20 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Kub Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kub Technologies, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Kub Technologies, Inc.” (first 2007, latest 2021), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kub Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kub Technologies, Inc. is 148 days. Since 2017: 154 days, versus 53 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kub Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MWP (Cabinet, X-Ray System, 6); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 10 Kub Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MWP, Kub Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.